N/A
Completed N=22
Evaluation of the Candela 1064nm:Nd:YAG Laser for Skin Tightening
Localized Lipodystrophy
Source: ClinicalTrials.gov NCT00585715 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Mild to Moderate Reduction in Cellulite. — 3; 2 participants
Summary
The purpose of this research study is to evaluate effectiveness of a non-ablative (does not remove skin) treatment for cellulite (dimpled fat) in conjunction with skin tightening using the Candela GentleYAG laser.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Mild to Moderate Reduction in Cellulite. |
3; 2 | — |
| PRIMARY Average Extent of Reduction in Cellulite Appearance for Patients With Reported Mild to Moderate Cellulite Reduction. |
1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals, male or female, greater than 40 years of age.
- Moderate skin laxity in the arms, legs, abdomen, or neck.
- Subject is not overweight. Body Mass Index (B.M.I.) is ≤ 27.
- Subject has Fitzpatrick skin phototype I-IV.
- Subject is willing to participate in study and adhere to follow-up schedule.
- Subject is able to read and comprehend English.
- Subject has completed Informed Consent Form.
Exclusion Criteria
- Subjects that have had liposuction or other surgical procedures (including mesotherapy) to remove fat in the treatment area during the past year.
- Subject is overweight (BMI > 27).
- Subject has known photosensitivity or history of ingesting medications known to induce photosensitivity in the previous 3 months.
- Subject has a personal or family history of keloid formation or scarring.
- Subject is pregnant or lactating.
- Subject has a history of uncontrolled diabetes and/or requires medication which may interfere with the study.
- Subjects with a known history of neuropathy.
- Subjects with a known history of a coagulopathy.
- Subject is unable or unwilling to comply with the study requirements
- Subject has pacemaker or metallic implants.
- Subject has Fitzpatrick skin type V and VI.
- Subject is mentally incompetent or a prisoner.
Data sourced from ClinicalTrials.gov (NCT00585715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.